Takayuki Iwamoto    Department   Kawasaki Medical School  Kawasaki Medical School, Department of Breast and Thyroid Surgery,    Position   Assistant Professor
Article types	原著
Language	English
Peer review	Peer reviewed
Title	A Phase I Trial of 100 mg/m2 Docetaxel in Patients with Advanced or Recurrent Breast Cancer.
Journal	Formal name：Acta medica Okayama Abbreviation：Acta Med Okayama ISSN code：0386300X/0386300X
Domestic / Foregin	Foregin
Volume, Issue, Page	70(5),pp.425-427
Author and coauthor	Tomoki Tamura, Taizo Hirata, Masahiro Tabata, Shiro Hinotsu, Akinobu Hamada, Takayuki Motoki, Takayuki Iwamoto, Taeko Mizoo, Tomohiro Nogami, Tadahiko Shien, Naruto Taira, Junji Matsuoka, Hiroyoshi Doihara
Publication date	2016/10
Summary	Docetaxel is a standard treatment for patients with advanced or recurrent breast cancer. The recommended dose is 60 to 100 mg/m2. Previous study have shown that the tumor response rates of patients who received docetaxel monotherapy at doses of 60, 75, and 100 mg/m2 were 22.1% , 23.3% , and 36.0% , respectively, and there was a significant relationship between the dose and response. In Europe and the United States, docetaxel is approved at a dose of 100 mg/m2, and Japanese guidelines also recommend a dose of 100 mg/m2. However, the approved dose in Japan is up to 75 mg/m2. We have launched a phase I trial evaluating 100 mg/m2 docetaxel in patients with advanced or relapsed breast cancer. The major eligibility criteria are as follows: age 20 years, pathologically diagnosed breast cancer, recurrent or advanced breast cancer, a good performance status, and HER2 [human epidermal growth factor receptor 2] negative. The primary endpoint is demonstrated safety of 100 mg/m2 docetaxel. This study will clarify whether 100mg/m2 docetaxel can be administrated safely in Japanese patients with advanced or recurrent breast cancer.
DOI	10.18926/AMO/54607
PMID	27777441